(f) the name of the licensed dealer from whom the purchase of the drug will be made.

J.01.018 Where the Minister receives from an institution an application or a copy of an application made pursuant to section J.01.015, he may, subject to such qualifications and limitations as he deems proper, authorize

(a) the sale to the institution by a licensed dealer of the restricted drug applied for in such quantity and such dosage form as he deems proper; and

(b) qualified investigators to make clinical use of the restricted drug in the institution or to carry out laboratory research with the restricted drug in the institution and to possess the restricted drug for the purposes of such use or research.

J.01.019 An institution shall use a restricted drug only for the purpose and in accordance with the protocol therefor set out in the application respecting that restricted drug made pursuant to section J.01.015.

J.01.020 Where a licensed dealer is authorized under section J.01.018 to sell a restricted drug, he may, notwithstanding section C.08.002, sell that drug subject to any qualifications or limitations imposed by the Minister.

Records and Inspection

J.01.021 Every institution shall keep and retain for a period of two years from the date of the making of the record, a record of

(c) the names and qualifications of every person who makes use of a restricted drug in the institution; and

(d) full clinical data with respect to the use of every restricted drug received by the institution.

SOR/85-550, s. 15.

J.01.022 Every institution shall make its records referred to in section J.01.021 available to the Minister upon his request and shall permit such inspection of the institution, respecting its use of restricted drugs, as the Minister may require.

(a) the name, quantity and form of any restricted drug received by them, the name and address of the person who sold or provided it and the date it was received;

(b) the name, quantity and form of any restricted drug sold or provided by them, the name and address of the person to whom it was sold or provided and the date it was sold or provided;

(c) the name, quantity and form of any restricted drug they have used in making or assembling a product or compound containing that restricted drug, the name and quantity of the product or compound made or assembled and the date on which the product or compound was placed in stock;

(d) the name and quantity of any restricted drug produced and the date on which it was placed in stock; and

(e) the name, quantity and form of any restricted drug he has in stock.

J.01.024 Every licensed dealer and every person who has been a licensed dealer shall keep the record referred to in section J.01.023 on the premises described in the licence that was issued to him or in such other place as may be approved by the Minister for a period of at least two years and shall keep such record in a form that will facilitate an audit thereof being made at any time.

J.01.025(1) The Minister may, in respect of an applicant for a dealer’s licence or a licensed dealer, require an inspection, at any reasonable time, of

(a) the premises used or intended to be used in producing, making, assembling or storing a restricted drug; and

(b) the process and conditions of the producing, making, assembling or storing.

J.01.028 Every licensed dealer who is in possession of a restricted drug, every institution to which the sale of such a drug has been authorized by the Minister and every person who is in possession of a restricted drug other than a restricted drug listed in Part II of the schedule to this Part shall

(a) provide such protection against loss or theft of the restricted drug as may be required by the Minister; and

(b) report forthwith to the Minister and to local law enforcement authorities any loss or theft of a restricted drug.